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FDAnews has compiled a list of the 21st Century Cures Act’s requirements and deadlines most relevant to the FDA and the pharmaceutical industry, including upcoming guidances, policies and public reports. Read More
The FDA plans to conduct two studies to gauge whether consumers and healthcare professionals have the capacity to detect and report deception prescription drug advertisements. Read More
The FDA refused to approve Cempra’s community-acquired bacterial pneumonia antibiotic Solithera, citing manufacturing and safety concerns in a complete response letter. Read More